Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate the efficacy of two dentifrices for dentine hypersensitivity

Conditions: Dentine Sensitivity

Summary: an 8 week clinical study to evaluate the ability of an experimental dentifrice containing calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate and sodium monofluorophosphate.

a single centre, multi-site, randomised, examiner blind, two treatment, parallel group, non-inferiority design clinical study conducted in healthy subjects with self-reported and clinically diagnosed dentine hypersensitivity (dh). this study will compare the effectiveness of a test dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium fluoride to a commercially available dentifrice containing 5% w/w calcium sodium phosphosilicate and fluoride as sodium monofluorophosphate, in providing relief from dh after 4 and 8 weeks twice daily treatment.

Eligibility criteria:
inclusion criteria: * subjects in good general health with no clinically significant/ relevant abnormalities of oral examination * pre-existing self reported and clinically diagnosed tooth sensitivity * at screening a minimum of 20 natural teeth and at least two accessible, non-adjacent teeth (incisors, canines or pre-molars) with signs of erosion or abrasion and/or facial/cervical gingival recession (ear), with a gingival index ≤1 and clinical mobility ≤1, and with signs of dh as measured by qualifying evaporative (air) assessment * at baseline, a minimum of 2 non-adjacent accessible teeth (incisors, canines or premolars) with dh (qualifying tactile threshold yeaple ≤ 20g, schiff sensitivity score ≥ 2) exclusion criteria: * subjects with a known or suspected intolerance or hypersensitivity to study products * presence of chronic debilitating disease which could affect study outcomes * any condition which is causing dry mouth * use of an oral care product indicated for the relief of dentine hypersensitivity * participation in a dh treatment study in the 8 weeks prior to screening * taking daily doses of a medication/ treatment which could interfere with perception of pain or is causing dry mouth * require antibiotic prophylaxis for dental procedures * dental prophylaxis within 4 weeks of screening * treatment of periodontal disease within 12 months of screening+c60 * scaling or root planing within 3 months of screening * tooth bleaching within 8 weeks of screening * active caries or periodontitis * partial dentures, orthodontic appliances or dental implants which could affect study outcomes * pregnant and breast-feeding females * main exclusions for test teeth: evidence of current or recent caries; treatment of decay within 12 months of screening; teeth with exposed dentine but with deep, defective or facial restorations; teeth used as abutments for fixed or removable partial dentures; teeth with full crowns or veneers, orthodontic bands or cracked enamel; sensitive teeth with contributing aetiologies other than erosion, abrasion or recession
exploratory safety and effectiveness evaluation of pulsed field ablation (pfa) by balloon catheter with trupulse generator for treatment of paroxysmal atrial fibrillation (paf)

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to explore preliminary safety and acute effectiveness of pulsed field ablation by the ablation system (pulsed field ablation balloon catheter and trupulse generator) when used for isolation of the atrial pulmonary veins (pvs) in treatment of participants with paroxysmal atrial fibrillation (paf), an irregular heart rate that causes abnormal blood flow.


Eligibility criteria:
inclusion criteria: * diagnosed with symptomatic paroxysmal atrial fibrillation (paf) defined as af that terminates spontaneously or with intervention within 7 days of onset. this paf is considered to be symptomatic if symptoms related to af are experienced by the participant * selected for af ablation procedure by pulmonary vein isolation (pvi) * willing and capable of providing consent * able and willing to comply with all pre-, post-, and follow-up testing and requirements exclusion criteria: * previously known af secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity \[body mass index more than {\>} 40 kilogram per square meter {kg/m\^2}\], renal insufficiency \[with an estimated creatinine clearance less than {\<}30 milliliter {ml}/minute {min}/1.73 meter {m}\^2\]) * previous left atrium (la) ablation or surgery * participants known to require ablation outside the pulmonary vein (pv) region (example, atrioventricular reentrant tachycardia, atrioventricular nodal re-entry tachycardia, atrial tachycardia, ventricular tachycardia and wolff-parkinson-white) * previously diagnosed with persistent af (\>7 days in duration) * severe dilatation of the la (left anterior descending artery \[lad\] \>50 millimetre \[mm\] antero-posterior diameter or left atrium volume index \[lavi\] \>48 \[ml/m\^2\] in case of transthoracic echocardiography \[tte\])
phase iii clinical study of shr-2004 injection in preventing venous thromboembolism in patients undergoing total knee arthroplasty

Conditions: Prevention of Arterial and Venous Thrombosis

Summary: the purpose of the study is to evaluate the efficacy and safety of shr-2004 in preventing venous thromboembolism after elective unilateral total knee arthroplasty.


Eligibility criteria:
inclusion criteria: 1. understand the research procedures and methods, volunteer to participate in this trial, and sign the informed consent form in writing; 2. planned elective schedule total knee arthroplasty (tka) patients; 3. men or women who are ≥ 18 years old and \< 80 years old on the day of signing the informed consent form. exclusion criteria: 1. unable to receive ct angiography of both lower limbs; 2. malignant tumor within one year of the screening; 3. myocardial infarction, transient ischemic attack or ischemic stroke occurred within 6 months of the screening; 4. any medical history that may increase the risk of bleeding or any conditions that the investigator considers to increase the risk of bleeding; 5. history of drug abuse; 6. pregnant or lactating women.
safety and efficacy of the waisfix100i for intracapsular femoral fracture fixation

Conditions: Hip Fracture

Summary: the purpose of this study is to determine the safety and efficacy of using waisfix100i device for intracapsular femoral fracture fixation.

fractures of the neck of the femur represent an estimated cost to society that exceeds ten billion dollars annually in the usa only. fractures have been treated with immobilization, traction, amputation, and internal fixation throughout history. immobilization by casting, bracing, or splinting a joint above and below the fracture was used for most long bone fractures. several studies have suggested that reduction and fixation of an intracapsular fracture of the hip with multiple pins or screws is associated with a lower rate of morbidity and mortality than treatment with prosthetic replacement. with improved methods of fixation and a tendency toward earlier weight-bearing, internal fixation is believed to be a better mode of treatment for younger, more active patients. on the other hand, the internal fixation procedure may result with number of possibilities for serious complications and biomechanical disadvantages, leading to the device failure. this led to a growing tendency to prefer total or partial hip replacement as the common treatment for intracapsular fracture, although the internal fixation is the favorable procedure in the professional literature. orthomeditec has developed the waisfix100i device, a new concept for intracapsular femoral fracture fixation and bone grafting using minimally invasive procedures. the waisfix100i combines a new and unique internal triangular cage nail fixator and three lag screws. the internal triangular cage is inserted into the femoral neck as a strong, solid beam structure to guide and hold the screws in place. the cage supplies the structure to hold the bone graft and screws at the fracture site. the objectives of this single arm, multi-center, prospective study, are to evaluate the safety and efficacy of using the waisfix100i device in intracapsular femoral fracture fixation surgery.

Eligibility criteria:
inclusion criteria: 1. male/female with intracapsular femoral fracture type garden i-ii and several iii. 2. age 50 to 75. 3. subject able to comprehend and give informed consent for participation in this study. exclusion criteria: 1. known active infectious disease. 2. terminal diseases 3. patients in high risk and/or acute cardio-vascular disease. 4. known cognitive disorder, psychiatric and/or neurological disease 5. physician objection. 6. age under 50 or above 75. 7. concurrent participation in any other clinical study 8. patients cannot understand or not willing to sign the informed consent.

Keywords: hip prosthesis implantation
preliminary efficacy and safety study of st101 plus aricept in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study will investigate the ability of st101 to improve memory in people with alzheimer's disease who currently receive 10 mg aricept® (donepezil) per day. this study also will examine the safety and tolerability of the drug. this study is evaluating 3 different dose levels of st101 and placebo. patients will have a 1 in 4 chance of getting placebo. all eligible subjects will be provided with bottles of 10 mg aricept (donepezil) during the study drug administration part of the study.

alzheimer's disease (ad) is a progressive and fatal neurological illness. it produces changes in the brain that include loss of cells and accumulation of abnormal protein deposits. initial symptoms are cognitive, with deficiencies in short-term memory the most common symptom. as the disease progresses so does the severity of cognitive deficiency. loss of speech and immobility occur in the terminal stages there is no cure for ad and no marketed treatment that modifies the underlying disease process. available therapies improve some symptoms of ad by increasing brain concentrations of molecules involved in cognition. st101 differs from marketed therapies in that it has demonstrated two actions in animal research testing. it improves cognition and it also reduces the accumulation of abnormal protein deposits in the brain. these two properties suggest that st101 may be a promising agent for the treatment of ad. this study is designed as a preliminary dose exploration/proof-of¬concept investigation of the ability of st101 to improve cognition during 12 weeks of administration.

Eligibility criteria:
inclusion criteria: * subjects must be receiving concurrent treatment with 10 mg/day of aricept (donepezil). the dose shall have been stable for three (3) months (90 days) prior to screening. * diagnostic evidence of moderate to moderately severe probable alzheimer's disease * ct or mri results within the past 18 months that rule out dementia due to non-alzheimer's etiology. * a reliable and capable caregiver. exclusion criteria: * subjects who reside in a skilled nursing facility. * subjects with b12 or folate deficiency. * subjects with chronic hepatic disease. * subjects with a recent history of hematologic/oncologic disorders. * subjects who have experienced a myocardial infarction with the past year.

Keywords: dementia alzheimer type senile dementia cognitive impairment
study of platinum plus etoposide with or without tislelizumab in participants with untreated extensive-stage small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: this phase 3 study was a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy of tislelizumab in combination with either cisplatin or carboplatin and etoposide (arm a), compared to placebo combined with either cisplatin or carboplatin and etoposide (arm b), as a first-line treatment for participants with previously untreated extensive-stage small cell lung cancer (es-sclc).


Eligibility criteria:
key inclusion criteria: 1. age≥18 years old, male or female, signed informed consent form (icf). 2. eastern cooperative oncology group (ecog) performance status of 0 or 1 3. histologically or cytologically confirmed es-sclc 4. no prior systemic treatment for es-sclc 5. adequate hematologic and end organ function key exclusion criteria: 1. active leptomeningeal disease or uncontrolled, untreated brain metastasis; 2. prior therapy with an antibody or drug against immune checkpoint pathways, including but not limited to, anti program death receptor-1 (anti-pd-1), anti-pd-l1, or anti cytotoxic t lymphocyte associated antigen 4 (anti ctla-4) antibody; 3. was administered a live vaccine ≤ 4 weeks before randomization; 4. active autoimmune diseases or history of autoimmune diseases that may relapse 5. any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication ≤ 14 days before randomization; 6. with a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases; 7. severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks prior to randomization, including but not limited to tuberculosis infection; 8. participant with untreated hepatitis b virus (hbv)/hepatitis c virus (hcv), or a known history of hiv infection; 9. participants with toxicities (as a result of prior anticancer therapy) which have not recovered to baseline or stabilized at the time of randomization; 10. clinically significant pericardial effusion, or clinically uncontrolled pleural effusion note: other protocol defined inclusion/exclusion criteria may apply.
a phase i study of qls12004 in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this study is a single-arm, open, dose-escalation, and dose-expansion phase i clinical trial of qls12004 in patients with advanced solid tumors, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of qls12004 in subjects with advanced solid tumors.

this study is a single-arm, open, dose-escalation, and dose-expansion phase i clinical trial of qls12004 in patients with advanced solid tumors, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of qls12004 in subjects with advanced solid tumors.the frequency of administration and the dose to be administered in subsequent clinical studies will be determined based on a combination of preliminary data.

Eligibility criteria:
inclusion criteria: 1. volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (icf); 2. age ≥ 18 years when icf is signed; 3. at least one target lesion as defined per recist version (v) 1.1; 4. dose escalation phase: pts with histologically or cytologically confirmed advanced solid tumors, who have failed standard therapy or for whom no standard therapy is available; 5. dose escalation phase: hr+/her2-advanced breast cancer that has failed prior cdk4/6 inhibitor combined with endocrine therapy; 6. eastern cooperative oncology group performance status of 0 or 1; 7. adequate hematologic and organ function; 8. female subjects who are not pregnant or breastfeeding 9. male and female subjects able to have children must agree to use highly effective method of contraception throughout the study and for at least 90 days after last dose. exclusion criteria: 1. subjects with major cardiovascular and cerebrovascular diseases; 2. any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug; 3. subjects who have received chemotherapy, endocrine therapy, immunotherapy, and targeted therapy, other anti-tumor treatments, or participating in other clinical studies is less than 4 weeks before the first administration of investigational product; 4. known psychiatric or substance abuse disorders that would interfere with the requirements of the study; 5. hiv-positive or syphilis spiral antibody-positive persons; 6. major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose, or the need for elective surgery during the trial; 7. known hypersensitivity to the test drug or any of its excipients; 8. history or current evidence of any condition, therapy, or laboratory abnormality, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study, or investigators/sponsor consider the subjects are not suitable for this trial.
urinary continence of female poprc and oin

Conditions: Urinary Bladder Neoplasms; Woman; Sexual Dysfunction, Physiological; Treatment Outcome; Urinary Incontinence

Summary: to compare the urinary continence rate and long-term oncological outcomes of pelvic-organ preserving radical cystectomy (poprc) with orthotopic ileal neobladder (oin) versus standard radical cystectomy(src) with oin.

radical cystectomy is the gold standard for muscle-invasive bladder. orthotopic ileal neobladder, as one of the urinary diversion methods, is preferred whenever possible to achieve a better postoperative quality of life. for standard radical cystectomy (src) in females, the uterus, fallopian tubes, ovaries, anterior vaginal wall, and regional lymph nodes undergo en bloc resection with the bladder and urethra . with regard to the wide range of resection, continence disorder and sexual dysfunction are very common after surgery. pelvic-organ sparing radical cystectomy involves the preservation of the female vagina, uterus, neurovascular bundles, and any enhancement of the aforementioned techniques . previous studies demonstrated that poprc might not affect long-term survival and instead improve continence outcomes. however, most of the available studies are retrospective with limited cases in a single center. the current study primarily aims to urinary continence rate and long-term oncological outcomes of poprc+oin versus src+oin in a prospective randomized controlled trial.

Eligibility criteria:
inclusion criteria: 1. female patients aged between 55-75. 2. patients those who are diagnosed with organ-confined urothelial carcinoma（\<pt3） 3. patients those who are capable for radical cystectomy with orthotopic ileal neobladder. 4. ecog score between 0-2; 5. normal renal function; 6. patients those who volunteer to participate in this study and sign the informed consents. 7. patients those who are able to cooperate in the study. exclusion criteria: 1. absence of tumour in bladder neck or urethra; 2. patients thsoe who are diagnosed distant metastasis before surgery. 3. previous history of malignancy of pelvic organs or surgical resection of pelvic organs; 4. patients those who are diagnosed with other malignancies.; 5. patients those who had received pelvic radiotherapy or major pelvic operation. 6. pregnancy status; 7. any other conditions that the researcher considers to be excluded from this study

Keywords: bladder cancer, female, pelvic organ preserving-radical cystectomy, radical cystectomy, orthotopic ileal neobladder
evaluation of efficacy of online real-time home cpr training program

Conditions: Cardiopulmonary Resuscitation; Cardiopulmonary Arrest; Education

Summary: the purpose of this study is to evaluate the effectiveness of a real-time home cpr(cardiopulmonary resuscitation) training program. the study participants will be allocated to two different cpr training programs. the intervention group will participate in the real-time home cpr training program while the control group will participate in the conventional cpr training program. the investigators will compare the quality of chest compression between the two study groups. the investigators hypothesize that the new real-time home cpr training program is non-inferior to the preexisting conventional cpr training program.

bystander cpr(cardiopulmonary resuscitation) is important for the survival of out-of-hospital cardiac arrest patients. cpr training for the general public is important to improve the rate and quality of bystander cpr. conventional cpr education was conducted under face-to-face contact with instructors and multiple trainees gathered at a training center, but after the coronavirus disease 2019 pandemic, face-to-face training became difficult. to overcome this limitation the investigators have developed a new real-time home cpr training program. the training program delivers little anne qcpr mannequins (laerdal, stavanger, norway) to each participants homes and the participants use an application specifically developed for cpr training that automatically connects wirelessly to the little anne qcpr mannequin through bluetooth so that the instructor can give real-time feedback on chest compression quality to participants. the purpose of this study is to evaluate the effectiveness of a real-time home cpr(cardiopulmonary resuscitation) training program. the study participants will be allocated to two different cpr training programs. the intervention group will participate in the real-time home cpr training program while the control group will participate in the conventional cpr training program. the investigators will compare the quality of chest compression between the two study groups. chest compression quality at the start of both training programs and after completion of the programs will be measured by little anne qcpr mannequins used in the training programs. the investigators hypothesize that the new real-time home cpr training program is non-inferior to the preexisting conventional cpr training program.

Eligibility criteria:
inclusion criteria: * adults without prior cpr training within 6 months exclusion criteria: * healthcare providers

Keywords: cardiopulmonary resuscitation education